Lupin, Dr Reddy's, Sun get USFDA nod for mental disorder drug

Three Indian drug majors, Lupin, Dr Reddy's, Sun Pharma have got approvals from the US health regulator to sell generic quetiapine fumarate tablets, used in treating mental disorders, in the American market.

In separate statements, Lupin, Dr Reddy's, Sun Pharma said the approvals from the US Food and Drug Administration (USFDA) were for multiple strengths of the drug in 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg.

"We expect close to 90 per cent price erosion due to competition and we are confident that we will garner healthy market share of the product given our track record and excellent trade relations within the US market," a Lupin spokesperson said.

The company has already commenced shipping product, he added.

Similarly, Hyderabad-based Dr Reddy's Laboratories said it has launched the generic drug in the US market.

Mumbai-headquartered Sun Pharmaceutical Industries said the approval has been granted to its US subsidiary

The quetiapine fumarate tablets are generic equivalent of AstraZeneca's Seroquel Tablets. According to IMS Health December 2011 data, AstraZeneca's Seroquel Tablets had sales of USD 4.6 billion.

Quetiapine is a psychotropic agent, indicated for treatment of schizophrenia and acute treatment of manic episodes associated with mental disorder. The drug is also indicated as monotherapy for the acute treatment of depression.

Shares of Lupin were trading at Rs 515 on the BSE in the afternoon trade, up 0.48 per cent from its previous close, while that of Dr Reddy's Laboratories were trading at Rs 1,715 on the BSE, up 2.08 per cent. Sun Pharma shares were trading at Rs 570.10 on the BSE, down 0.91 per cent from its previous close.